12:56 EST 27th January 2019 | BioPortfolio
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Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula:

Each rectal suppository contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable oil base

In normal subjects, about 26% of hydrocortisone acetate is absorbed when the suppository is applied to the rectum. Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces. Topical steroids are primarily effective because of their anti-inflammatory, anti-pruritic and vasconstrictive action.

Hydrocortisone acetate suppositories are indicated for the use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and puritus ani.

Hydrocortisone Acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components

Do not use unless adequate proctologic examination is made. If irritation develops, the product should be discontinued and appropriate therapy instituted. In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Carcinogenic: No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

The following local adverse reactions have been reported with hydrocortisone acetate suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.

To report suspected adverse reactions, contact

Graxcell pharmaceutical, llc.

1-888-266-8818 or

FDA @ 1-800-FDA-1088 or

If signs and symptoms of systemic overdosage occur, discontinue use.

Usual Dosage: One suppository in the rectum morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily: or two suppositories twice daily. In factitial proctitis, recommended therapy in six to eight weeks or less, according to the response of the individual case.

Rx only.


Avoid excessive handling of the suppository. It is designed to melt at body temperature.

1. Separate plastic film at top opening and pull downward.

2. Continue pulling downward to almost the full length of the suppository.

3. Gently remove the suppsitory from the film pocket.

Hydrocortisone Acetate suppositories 25mg are white,cyclinder shaped, with one end tapered.

Package of 12 NDC 70795-2412-1


Package of 24 NDC 70795-2412-2

Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. Store away from heat. Protect from freezing.

Manufactured for:

Graxcell pharmaceutical, LLC.

130 knickerbocker ave,Bohemia, NY 11716

Manufactured by:

Graxcell pharmaceutical, llc.

136 OAk Drive,

syosset, NY 11791


Drug abuse and dependece have not been reported in patients treated with Hydrocortisone acetate suppositories.



Active Ingredients


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Clinical Trials [962 Associated Clinical Trials listed on BioPortfolio]

Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids

The objectives of this study are to assess the potential contribution of lidocaine hydrochloride or hydrocortisone acetate, alone or in combination, in topical cream preparations in the tr...

Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Suppositories

This study will be an open label, single dose, randomized, 2 way (2 period) crossover study in healthy adult subjects at a single study center.

Study of the Safety and Efficacy of Hydrocortisone Acetate Suppositories, 25 mg in the Treatment of Symptomatic Internal Hemorrhoids

A randomized, double-blind, placebo-controlled, multicenter, parallel group study of the safety and efficacy of Hydrocortisone Acetate Suppositories, 25 mg compared to placebo suppositorie...

UVB Model Validation Study

Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induc...

Androgen Reduction in Congenital Adrenal Hyperplasia

Children with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency tend to have elevated circulating levels of androgens, which can accelerate skeletal maturation and adve...

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Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula: A Randomized Clinical Trial.

Both hydrocortisone and pasireotide have been shown in randomized clinical trials to be effective in reducing postoperative complications of pancreatic surgery, but to date no randomized clinical tria...

Hydrocortisone for Preventing Mortality and Bronchopulmonary Dysplasia in Preterm Infants with or without Chorioamnionitis Exposure: A Meta-Analysis of Randomized Trials.

 This study sought to assess whether infants exposed to chorioamnionitis are the optimal population to benefit the most from early postnatal hydrocortisone delivery in preventing bronchopulmonary dy...

Neodymium as an alternative contrast for uranium in electron microscopy.

Uranyl acetate is the standard contrasting agent in electron microscopy (EM), but it is toxic and radioactive. We reasoned neodymium acetate might substitute uranyl acetate as a contrasting agent, and...

Cortisol affects pain sensitivity and pain-related emotional learning in experimental visceral but not somatic pain: a randomized controlled study in healthy men and women.

Despite growing interest in the role of stress mediators in pain chronicity, the effects of the stress hormone cortisol on acute pain remain incompletely understood. In a randomized, double-blind, pla...

Effects of hydrocortisone administration on leptin and adiponectin synthesis in dogs.

To determine effects of hydrocortisone administration on serum leptin and adiponectin concentrations, abdominal fat distribution, and mRNA expression of leptin and adiponectin in abdominal adipose tis...

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